Cleared Traditional

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX (K911501) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911501 · Shimadzu Medical Systems · Radiology device
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Jul 1991
Decision
105d
Days
Class 2
Risk

K911501 is an FDA 510(k) clearance for the SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shimadzu Medical Systems devices

Submission Details

510(k) Number K911501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1991
Decision Date July 17, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 385
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K911501.
CT SYTEC 8000
K913485 · General Electric Co. · Jan 1992
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K913996 · Siemens Medical Solutions USA, Inc. · Nov 1991
KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE
K912454 · Eastman Kodak Company · Sep 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
K910859 · Siemens Medical Solutions USA, Inc. · May 1991
CT SYTEC 4000
K911387 · GE Medical Systems · May 1991
CT HILIGHT ADVANTAGE II
K904971 · GE Medical Systems · Jan 1991